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NCT02079090

Ketofol Versus Fentofol for Procedural Sedation of Children 3 to 17 Years Old: a Double-Blind Randomized Controlled Trial

Completed Phase 3 Last updated 25 October 2017
What this trial tests

Phase 3 trial testing Ketofol in Emergency Department Procedural Sedation in 30 participants. Completed in 1 June 2017.

Timeline
1 July 2014
Primary endpoint
1 June 2017
1 June 2017

Quick facts

Lead sponsorUniversity of British Columbia
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment30
Start date1 July 2014
Primary completion1 June 2017
Estimated completion1 June 2017
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of British Columbia

Who can join

Adults 3 to 17, any sex, with Emergency Department Procedural Sedation or Fracture Reduction. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

Sedation and pain medication is required when bone fractures need to be fixed in the emergency department (ED). Many drugs have been used safely as single agents or in combination for the sedation of children. These drugs include Propofol, Ketamine and Fentanyl. However each of these medications has side effects and drawbacks. The combination of Propofol and Fentanyl (Fentofol) has never been compared directly with the combination of Propofol and Ketamine (Ketofol) for painful procedures in the ED, and the goal of this study is to determine which combination works better. The primary outcome of this study is to determine which drug combination has a shorter time from onset of sedation to full recovery. The investigators hypothesize that Fentofol will have shorter sedation to recovery times.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Ketofol

Trials testing the same drug.

Other University of British Columbia trials

Trials by the same sponsor.

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Data sources for this page

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